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Guardian Splint

FDA UDI

Class I (US FDA UDI)

by Bm Korea Co., Ltd

Identity

Trade Name
Guardian Splint FDA UDI
Generic Name
First aid limb splint, non-mouldable, reusable FDA UDI
Device Name
This product is made by molding thermoplastic synthetic resin to the affected area, and is used to support and immobilize the joint and surrounding areas. FDA UDI
Model / Reference
GSL-S FDA UDI
Description
This product is made by molding thermoplastic synthetic resin to the affected area, and is used to support and immobilize the joint and surrounding areas. FDA UDI

Identifiers

Primary DI / UDI-DI
08809818038135 FDA UDI
FDA Product Code
NOC FDA UDI
GMDN Term
First aid limb splint, non-mouldable, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.3910 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 300 Millimeter FDA UDI
Width — 100 Millimeter FDA UDI

Category: First aid limb splint, non-mouldable, reusable

Guardian Splint by Bm Korea Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as First aid limb splint, non-mouldable, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bm Korea Co., Ltd

Sources (1)

  • FDA UDI ea13fc39-9a4f-4691-9459-79a68475a28b 34 fields · synced May 29, 2026